Related by context. Frequent words. (Click for all words.) 55 CFATS 54 END FOOTNOTE 54 Act PDUFA date 54 REMS 53 PDUFA 53 IND submission 53 FDA 53 Act PDUFA 52 Mitigation Strategy REMS 52 BLA submission 52 By Arek Sarkissian 52 CFR Part 51 Biologics License Application 51 CDER 51 Prescription Drug User Fee 51 QbD 51 FDA Accepts 50 Pirfenidone 50 supplemental Biologics License Application 50 prGCD 50 CDRH 50 QNEXA 50 Risk Evaluation 50 Phases II 50 Biologics License Application BLA 50 Pharmacopeia USP 50 SUPPLEMENTARY INFORMATION 49 FIRAZYR 49 IIb 49 Vilazodone 49 NEBIDO 49 FENTORA 49 Investigational Device Exemption 49 PREOS 49 Orphan Drug status 49 Telavancin 48 CGMP 48 Prescribing Information 48 KENNETH C. CROWE 48 Complete Response 48 sBLA 48 orphan designation 48 Scientific Advice 48 NDA submission 48 alogliptin 48 Full Prescribing Information 47 ATryn R 47 Clolar 47 taliglucerase alfa 47 CORTOSS 47 FIFRA 47 Proposed Rule 47 PDUFA date 47 FDA approvable letter 47 NeutroSpec 47 alvimopan 47 NUVIGIL 47 Market Approval PMA 47 CFR § #.# [007] 46 ATryn ® 46 orphan medicinal product 46 Lumizyme 46 approvability 46 Marketing Authorization 46 BrachySil 46 LIALDA 46 Afluria 46 Icatibant 46 Bioterrorism Act 46 Hatch Waxman 46 Research CDER 46 GMPs 46 DSHEA 46 RoHS Directive 46 GPhA 46 Exelbine 46 Horizant 46 Safe GRAS 46 Controlled Substances 46 clinical endpoints 46 Citizen Petition 46 System NIMS 46 Zelrix 46 Appendices 46 Project Bioshield 46 VPRIV 46 NASA Authorization 45 Complete Response Letter 45 IPLEX 45 Drug Administration FDA 45 subpart 45 Tygacil 45 Nortel remedial 45 Boxed Warning 45 Capital Disclosures 45 RFS2 45 Regulatory Flexibility Act 45 sNDA 45 #/#/EC [002] 45 TSCA 45 CE Marking